Evaluation of the efficacy of amineptine in a population of 1,229 depressed patients: results of a multicenter study carried out by 135 general practitioners
Paes de Sousa M, Tropa J
Department of Psychiatry,
Santa Maria Hospital,
Lisbon, Portugal.
Clin Neuropharmacol 1989; 12 Suppl 2:S77-86


To assess the efficacy, tolerance, and safety of amineptine in ambulant treatment of depressive states, an open multicenter trial was performed by 135 general practitioners in a large number of depressed patients (1,229) with different nosologies and living in all areas of Portugal. The protocol included criteria of inclusion and exclusion and the full methodology was discussed with the practitioners in previous meetings coordinated by a psychiatrist. Daily dosage was 200 mg (two tablets); other psychotropic drugs were associated rarely and only when strictly necessary. Assessments were made at day 0, 7, 28, and 56, using the Clinical Global Impressions (CGI), Hamilton Depression Rating Scale (HDRS), diagram HARD, and a list of side effects. Results were analyzed statistically with calculation of statistical significance. The calculation of the correlation coefficients between the different measurement instruments was also made. There were 84 dropouts mainly due to missed appointments and intolerance of the medication. It is worth noting that 50% of the patients were treated with monotherapy, and that other psychotropics used were almost always anxiolytic drugs. Efficacy of amineptine was very good and rapid since there was a statistically significant difference in all observations with the different instruments of measurement used. Results were good in all types of depression, mainly in the neurotic and reactive ones. Moderate or severe side effects were seldom observed and transient. The acceptability was good or very good in 97.1% of the cases.
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